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Medtronic Infuse Bone Graft

FDA Grants Limited Approval for Medtronic Infuse Bone Graft

The Infuse Bone Graft was approved by the FDA on July 2, 2002. According to the manufacturer’s (Medtronic) website, the product is intended to be used to treat Lumbar Degenerative Disk Disease (DDD). It is also approved to treat a spinal condition called Degenerative Disc Disease; open fractures of the tibia; and two dental bone grafting procedures—sinus augmentation and localized alveolar ridge augmentation. The product is not approved for cervical procedures.

Purpose & Design

Traditionally lumbar degenerative disc disease is treated by performing a spinal fusion surgery. This surgery requires a portion of a hip bone to be harvested before it is used in the spinal fusion. It is intended to eliminate the need to use a portion of the hip bone by encouraging bone growth.

The Infuse Bone Graft consists of two parts: rhBMP-2, a protein that is found in everyone’s body, and a natural carrier for delivery. RhBMP-2 (recombinant (engineered) human bone morphogenetic protein-2) produces naturally in small amounts to regulate bone growth and healing. The second part of the it (the natural carrier) is a sponge manufactured from bovine (cow) Type 1 collagen. It releases the protein over time where it is placed, provides a scaffold (framework) for new bone to grow into, and is absorbed and eventually replaced by bone.

FDA Warns Against Infuse Bone Graft Procedure in Cervical Spine Procedures

In July of 2008, the FDA warned against use of Infuse Bone Graft for off label use in cervical spine procedures. The warning noted that patients who had undergone the procedure reported difficulty swallowing, speaking, and breathing. Several of these patients required emergency treatment—including tracheotomies and the insertion of feeding tubes— as well as second surgeries. Complications generally develop within two to fourteen days after the surgery.

Off Label Uses

The FDA prohibits medical device and pharmaceutical manufacturers from promoting their products for use in a manner that has not been approved by the FDA. In other words, a manufacturer can only promote a device for its FDA approved uses.

This restriction, however, does not apply to doctors, who are free to use medical devices and prescribe pharmaceuticals in any manner that they believe will benefit the patient. This practice, which is referred to as “off label” use,” is surprisingly quite common, and has lead to serious injuries and death.

In September of 2008, the Wall Street Journal reported that at least seventy-five percent of the 280 reported complications with the Medtronic Bone Graft involved off-label use. At least 38 of these reported complications were directly related to using the product for cervical spine applications. Most of these complications involved unwanted bone growth near nerves or in areas beyond the targeted fusion site. Medtronic attempted to discount the large number of complications caused by the Infuse Bone Graft by emphasizing that 680,000 units of Infuse Bone Grafts have been used in the United States to date.

Despite the large number of complications reported from cervical use of the Infuse Bone Graft, researchers from the Cleveland Clinic reported at the North American Spine Society that it was used “off label” in one out of every six surgeries.

Families Injured by the Medtronic Infuse Bone Graft Take Action

There have been at least three lawsuits filed again Medtronic arising from use of it in cervical spine (neck) procedures. The first lawsuit was filed by the family of a woman who received the Infuse Bond Graft in her neck and later died. The family alleges that the sales representative, who was present in the operating room when the procedure was performed, encouraged the off label use of the product.

In November 2008, U.S. Department of Justice issued a subpoena concerning the off label use of Medtronic Infuse Bone Grafts. Just one month later, a Medtronic Infuse wrongful death lawsuit was filed on behalf of a California woman who died after going into a coma caused by respiratory arrest following surgery. The Infuse bone replacement lawsuit alleged that Medtronic failed to warn about the risks associated with use of the device in the neck, and that Medtronic actively encouraged off-label uses, none of which have been approved by the FDA.

Three days after the California lawsuit was filed, Medtronic issued the following statement:

Medtronic’s technical consultant denies that he recommended the off-label use of the company’s product. FDA approved drugs and medial device products can be used by physicians in any way they deem proper, but companies are not allowed to promote off label applications or to induce physicians to do so.

The third lawsuit alleges that the graft used during the Plaintiff’s cervical spine fusion caused him to suffer severe swelling in the neck and throat, which impacted his ability to breath and required him to have an emergency tracheotomy. The lawsuit was filed against Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. in the U.S. District Court for the Southern District of New York.

Contact the Defective Medical Device Lawyers at Zehl & Associates Today: 1-888-603-3636

If you or a loved one experienced breathing or other health complications shortly after receiving a Medtronic Infuse Bone Graft in the cervical spine, you may have a claim against Medtronic for your personal injuries and economic damages. Call 1-888-603-3636 today for a free, no-commitment consultation.

The Medical Device Lawyers at Zehl & Associates have successfully resolved cases against major medical device and pharmaceutical companies located all over the world, and will devote whatever time and resources are necessary to obtain the maximum recovery for your injuries.